Transcatheter valve prosthesis

ABSTRACT

A system for implanting a heart valve that includes a radially self-expandable tubular body having an inflow end and a preformed groove disposed at an outer surface of the tubular body between the inflow end and the outflow end, wherein the preformed groove extends at least partially around the tubular body and having a circumferential opening facing radially outward of the tubular body. A valve may be disposed within and attached to the tubular body. Additionally, a trapping member may be configured to form at least a partial loop encircling the preformed groove so as to trap portions of native valve leaflets and/or chords in the preformed groove, the trapping member including one or more barbs.

TECHNICAL FIELD

Embodiments generally relate to a transcatheter valve prosthesis,especially a transcatheter atrio-ventricular valve prosthesis.

BACKGROUND

Heart valve diseases are affecting approximately 300,000 peopleworldwide each year. Those diseases translate in abnormal leaflet tissue(excess tissue growth, tissue degradation/rupture, tissuehardening/calcifying), or abnormal tissue position through the cardiaccycle (e.g., annular dilation, ventricular reshaping) leading to adegrading valve function like leakage/blood backflow (valveinsufficiency) or a resistance to blood forward flow (valve stenosis).

Accordingly, a transcatheter valve prosthesis for functional replacementof a heart valve is desirable.

SUMMARY

Various embodiments of the invention provide a system for implanting aheart valve. The system may include a radially self-expandable tubularbody having an inflow end and a preformed groove disposed at an outersurface of the tubular body between the inflow end and the outflow end,wherein the preformed groove extends at least partially around thetubular body and having a circumferential opening facing radiallyoutward of the tubular body. A valve may be disposed within and attachedto the tubular body. Additionally, a trapping member may be configuredto form at least a partial loop encircling the preformed groove so as totrap portions of native valve leaflets and/or chords in the preformedgroove, the trapping member including one or more barbs.

Various embodiments of the invention further provide a method forimplanting a replacement valve in a patient's heart. The method mayinclude at least partially deploying from a delivery catheter a radiallyself-expandable tubular body having an inflow end and an outflow end, avalve disposed within a lumen of the tubular body, and a preformedgroove disposed at an outer surface of the tubular body between theinflow end and the outflow end, the preformed groove having acircumferential opening facing radially outward of the tubular body.Additionally, the method may include advancing a trapping member to format least a partial loop encircling the preformed groove and trappingportions of native valve leaflets and/or chords in the preformed groove,and at least partially piercing the portions of native valve leafletsand/or chords with one or more barbs on the trapping member to securethe tubular body to the portions of native valve leaflets and/or chords.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. The drawings are not necessarilyto scale, emphasis instead generally being placed upon illustrating theprinciples of the invention. In the following description, variousembodiments are described with reference to the following drawings, inwhich:

FIG. 1 shows schematically a transcatheter valve prosthesis according toembodiments, located in a connection channel of a human heart,

FIG. 1a shows a detail of a free end of a projection of the valveprosthesis according to embodiments,

FIG. 1b shows a detail of a free end of a projection of the valveprosthesis according to embodiments,

FIG. 2 shows a transcatheter valve prosthesis according to embodiments,

FIG. 2a schematically shows extension angles of projections according toembodiments,

FIG. 3 shows schematically a transcatheter valve prosthesis comprisingan elongate outer member according to embodiments located in aconnection channel of a human heart,

FIG. 4 shows a transcatheter valve prosthesis including a clampingmember according to embodiments,

FIG. 5 shows the transcatheter valve prosthesis including the clampingmember of FIG. 4 from a different perspective,

FIG. 6a shows a schematic cross section of a transcatheter valveprosthesis along A-A in FIG. 3,

FIG. 6b shows a schematic cross section of a transcatheter valveprosthesis along B-B in FIG. 3,

FIG. 6c shows a schematic cross section of a transcatheter valveprosthesis along C-C in FIG. 4 including a clamping member,

FIG. 6d shows a schematic cross section of a transcatheter valveprosthesis along C-C in FIG. 4 including a clamping member in anotherarrangement than shown in FIG. 6 c.

FIG. 7 schematically shows the interaction of a transcatheter valveprosthesis, heart tissue and an elongate outer member according toembodiments,

FIG. 8 shows a transcatheter valve prosthesis according to embodiments,

FIG. 9a shows a tubular body of a transcatheter valve prosthesis,

FIG. 9b shows a tubular body of a transcatheter valve prosthesis,

FIG. 10a schematically shows a transcatheter valve prosthesis includingan outer member,

FIG. 10b schematically shows a transcatheter valve prosthesis includingan outer member,

FIG. 10c schematically shows a transcatheter valve prosthesis includingan outer member,

FIG. 11a schematically shows the transcatheter valve prosthesisincluding an elongate outer member according to embodiments,

FIG. 11b schematically shows the transcatheter valve prosthesisincluding an elongate outer member according to embodiments,

FIG. 11c schematically shows the transcatheter valve prosthesisincluding an elongate outer member according to embodiments,

FIG. 11d schematically shows the transcatheter valve prosthesisincluding an elongate outer member according to embodiments,

FIG. 12 schematically shows the transcatheter valve prosthesis accordingto embodiments,

FIGS. 13a and 13b schematically show the transcatheter valve prosthesisaccording to embodiments,

FIG. 14 schematically shows the transcatheter valve prosthesis accordingto embodiments,

FIGS. 15a, 15b, and 15c schematically show the transcatheter valveprosthesis and insertion member,

FIGS. 16a and 16b schematically show the transcatheter valve prosthesisaccording to embodiments,

FIGS. 17a, 17b, 17c, 17d, and 17e schematically show the transcathetervalve prosthesis according to embodiments,

FIG. 18 schematically shows the transcatheter valve prosthesis accordingto embodiments,

FIG. 19 schematically shows the transcatheter valve prosthesis accordingto embodiments,

FIG. 20 schematically shows the clamping member according toembodiments,

FIG. 21 schematically shows the clamping member according toembodiments,

FIG. 22 schematically shows the clamping member according toembodiments,

FIG. 23 schematically shows the clamping member according toembodiments,

FIG. 24 schematically shows the clamping member according toembodiments,

FIGS. 25a, 25b, and 25c schematically show the clamping member accordingto embodiments,

FIG. 26 schematically shows the transcatheter valve prosthesis accordingto embodiments, and

FIG. 27 schematically shows the transcatheter valve prosthesis accordingto embodiments.

DESCRIPTION

The following detailed description refers to the accompanying drawingsthat show, by way of illustration, specific details and embodiments inwhich the invention may be practiced. These embodiments are described insufficient detail to enable those skilled in the art to practice theinvention. Other embodiments may be utilized and structural and logicalchanges may be made without departing from the scope of the invention.The various embodiments are not necessarily mutually exclusive, as someembodiments can be combined with one or more other embodiments to formadditional embodiments.

With reference to FIGS. 1, 1 a, 1 b and 2, a transcatheteratrioventricular valve prosthesis 1 for functional replacement of a(native) atrio-ventricular heart valve 5 in a connection channel 10 thatconnects an atrial heart chamber 15 with a ventricular chamber 20 andcomprising a connection channel wall structure 25 may comprise a tubularbody 30. The tubular body 30 may be disposed in the interior of theconnection channel 10 and extend along an axis 35. The axis 35 may bethe longitudinal axis 35 of the tubular body 30, which may be anelongated body. In the implanted condition, the axis 35 of the tubularbody 30 may, but need not necessarily, be aligned substantially coaxialto an axis of the connection channel 10. The tubular body 30 may beradially compressible so as to facilitate approach to and insertion intothe connection channel 10, e.g., using a catheter or the like, and thenbe radially expandable so as to closely engage the interior or innerside of the connection channel wall structure 25, and may comprise anartificial heart valve 40 (e.g., schematically shown in FIG. 6a )arranged within the tubular body 30.

The native atrio-ventricular heart valve 5 (e.g., a mitral valve or atriscupid valve) to be replaced has the generally circumferential wallstructure 25 forming the connection channel 10 (or through opening)between the atrial 15 and ventricular 20 chambers of the heart. Itincludes a circumferential valve annulus, valve leaflets opening theconnection channel/through opening and closing the connection channelthrough opening at a position close to the valve annulus, a generallycircumferential chord structure (chordae tendinae) connected between thevalve leaflets and generally circumferential papillary muscle(s), andsaid circumferential papillary muscle(s).

The artificial heart valve 40 may be attached to the tubular body 30 andmay be designed to serve as an artificial replacement valve for anatrio-ventricular heart valve (for example a mitral and/or a tricuspidvalve). The artificial valve 40 may comprise artificial flaps (e.g.,three flaps as schematically shown in FIG. 6a ) for functionalreplacement of the native heart valve. The tubular body 30 may beprovided with an outer circumferential groove 45. The outercircumferential groove 45 may be open to the radial outside of thetubular body 30. The circumferential groove 45 may define a groovebottom 46. The outer circumferential groove 45 may define a channel 47which is defined itself by the groove bottom 46 and axially (in axialdirection of the tubular body 30) opposite side walls 48, 49. The groovebottom 46 may separate the tubular body 30 into first and second bodysections 31, 32. The circumferential groove 45 may extend around a wholecircumference of the tubular body 30 or may only extend partially arounda circumference of the tubular body 30. The outer circumferential groove45 may be a continuous, that is non-interrupted, groove, or may be aninterrupted groove 45 having, for example, two or more circumferentialgroove portions 45 provided, for example, on the same axial level of thetubular body 30 that are interrupted by areas in which no recessedportion, which may provide the groove portion, is formed. Thecircumferential groove 45 may be located at an axial distance (alongaxis 35) from the axial ends of the tubular body 30, i.e. thecircumferential groove 45 may be spaced apart in an axial direction fromend portions of the tubular body 30.

As shown in FIG. 1, the first body section 31 may be the part of thetubular body 30 that is located above (e.g., proximal from) thecircumferential groove 45, and the second body section 32 may be thepart of the tubular body 30 that is located beneath (e.g., distal from)the circumferential groove 45. Both of the first and second bodysections 31, 32 may have a generally cylindrical shape. According toembodiments, the first body section 31 may have a generally conical orexpanding shape along the axis of the tubular body, with itscross-section diameter increasing from the groove 45, and the secondbody section 32 may be generally cylindrical. According to embodiments,both of the first and second body sections 31, 32 may have a conicalshape along the axis of the tubular body, with their respectivecross-sectional diameters increasing from the groove 45. Additionally,the outflow end of the tubular body may include a frustoconical shapethat slopes radially outward from the preformed groove toward theoutflow end when the outflow end, but not the inflow end, has beenreleased from a delivery catheter.

According to embodiments, the cross sections (along axis 35) of sections31 and/or 32 may be or contain non-circular shapes such as elliptical orD-shaped cross sections. In addition, the direction of curvature in theaxial profile (seen in an axial section along the tubular body 30)between the groove 45 and the first body section 31 and/or between thegroove 45 and the second body section 32 may change (from concavecurvature of the groove 45 to a convex curvature at the transitionbetween groove 45 and first and/or second body section 31, 32). Theaxially opposite side walls 48, 49 of the groove 45 may be part of thefirst and second, respectively, body sections 31, 32 and may axiallydelimit the first and second, respectively, sections 31, 32 towards thechannel 47 of the groove 45, as it is shown, e.g., in FIG. 8. A radialdiameter of the first body section 31 (e.g., at an end portion that isopposite to the second body section 32) of the tubular body 30 may belarger than any diameter of the second body section 32. This may allowone to more efficiently fix the prosthesis 1 in the connection channel10 as the first body section 31 having a larger diameter may provide abetter hold of the prosthesis 1 in the connection channel 10 byproviding a friction and/or (mere) form fit (e.g., caused by the firstbody section 31 being located in the atrial chamber 15 and having adiameter larger than a diameter of the connection channel 10).

As shown in FIG. 12, the tubular body 30 may include one or moredecorrelation portions 140 configured to dissociate axial and radialmovements between an inflow end and an outflow end of the tubular body30. For example, the decorrelation portions 140 may dissociate movementsbetween first body section 31 and second body section 32 (FIG. 1). Thedecorrelation portions may be disposed adjacent to and outside thecircumferential groove 45. As show in FIG. 12, the circumferentialgroove 45 may be disposed between the decorrelation portions 140 and theoutflow end of the tubular body 30, and for example, between the valve40 and the inflow end. In some embodiments, the decorrelation portionsmay each include flexible “S” shaped portions or a flexible material,such as polyester fabric. In other embodiments, the decorrelationportions 140 may include a combination of such components. Thedecorrelation portions are generally configured to stretch or compressin reaction to movement in the outflow or inflow ends. Thus, because thedecorrelation portions stretch and/or compress, movement from one end ofthe tubular body does not translate/communicate to the other end of thetubular body. In this manner, movement in the ends of the tubular bodydo not correlate with one another.

Further, the valve prosthesis 1 may comprise a first plurality ofprojections 50 and a second plurality of projections 55. The projections50, 55 may extend from the first and second sections 31, 32,respectively, in opposite axial directions, that is at least with anextension component or an extension vector in a direction along the axis35 (e.g., the longitudinal axis 35) of the tubular body 30. Accordingly,the first projections 50 and the second projections 55 extend generallytowards each other, whereby they may not extend exactly or in linetowards each other, but with an extension vector. The projections 50, 55may extend substantially parallel to the axis 35 of the tubular body 30or may also extend in a (lateral) angle γ to the axis 35 of the tubularbody 30, wherein the (lateral) angle γ extends tangential to thecircumference of the tubular body 30, as it is shown, e.g., in FIG. 2 a.

The valve prosthesis 1 may comprise one plurality of projections 50, 55that may extend from the first or second sections 31, 32 in an axialdirection of the tubular body 30 and may overlap the circumferentialgroove 45. With reference to, e.g., FIGS. 11a-c , the valve prosthesis 1may not comprise any projections 50, 55, and the circumferential groove45 may be provided with (e.g., integrally formed on) the tubular body30.

The projections of the first plurality of projections 50 each may have afirst end 67 and a second end 69 (FIGS. 13a and 13b ). The first end 67may be connected to the tubular body 30 and the second end 69 may form afree end unattached to the tubular body 30. For example, the firstplurality of projections 50 may include free ends 60 and the secondplurality of projections 55 may include free ends 65 (FIG. 1). The freeends 60, 65 of the first and second pluralities of projections 50, 55may be arranged so as to overlap the outer circumferential groove 45.That is, the free ends of the first and second pluralities ofprojections 50, 55 are arranged at an axial level of the groove 45 so asto overlap the groove 45. The first and second pluralities ofprojections 50, 55 as such may at least partially or completely overlapthe groove 45 along their extension.

The first 50 and second 55 pluralities of projections may extend in aradial distance radially outwards of the bottom 46 of the groove 45 sothat a hollow (circumferential) chamber 66 is defined between the groovebottom 46 and the first and second pluralities of projections 50, 55 inthe channel 47. The opposite side walls 48, 49 may further define thehollow chamber 66 in the axial direction of the tubular body 30. Hence,the hollow chamber 66 may be confined radially by the pluralities ofprojections 50, 55 and the groove bottom 46 and axially by oppositesidewalls 48, 49 (e.g., top- and bottom-walls) of the groove 45.

In embodiments, the second ends 69 of projections 50, 55 may includebarbs configured to penetrate tissue (FIG. 1a ). In other embodiments,the second ends 69 may include blunt ends configured not to penetratetissue, for example substantially flat ends 166 extending in a directionsubstantially parallel to a tangent T of the tubular body 30 (FIGS. 13aand 13b ), or a plurality of struts 110 forming rounded (e.g., roundedcorner triangle) configurations (FIG. 14). In yet additionalembodiments, some or all of projections 50, 55 may include barbs, bluntends, and/or rounded configurations. Transcatheter valve prosthesis 1may include, in embodiments, the first plurality of projections 50and/or the second plurality of projections 55. In these embodiments thefirst plurality of projections 50 or the second plurality of projections55 may extend a sufficient distance so that the hollow chamber 66 isdefined between the groove 45 and the first plurality of projections 50and/or the second plurality of projections 55. Alternatively oradditionally, the first plurality of projections 50 and/or the secondplurality of projections 55 may define the circumferential groove 45between the tubular body 30 and the projections 50 and/or 55, e.g.,without indenting of the tubular body. For example, as shown in FIGS.16b and 19, circumferential groove 45 is defined between the tubularbody 30 and the second plurality of projections 55. A method of using atranscatheter valve prosthesis 1 may comprise positioning it in theconnection channel wall structure 25 of a heart and then insertingtissue that is adjacent to the circumferential groove 45, of theconnection channel wall structure 25 into the circumferential groove 45,for example to be placed radially below the first and second pluralityof projections 50, 55. The tissue can then be held in place in thecircumferential groove 45, for example by the first 50 and/or secondplurality of projections 55, which, if, for example, provided with acuteor sharpened ends, may penetrate into the tissue which from its positionbelow may be biased back to its initial radial position. The prosthesis1 may be positioned such that its outer circumferential groove 45 is atthe level of the annulus of the circumferential wall structure 25 oradjacent thereto towards the side of the ventricular chamber 20. By thefirst and second plurality of projections 50, 55 keeping the tissuewithin the groove 45, the transcatheter valve prosthesis 1 can bepositioned and fixed relative to the heart. Further, since the first andsecond plurality of projections 50, 55 axially extend towards eachother, the prosthesis is safely and reliably prevented from beingaxially pushed out of the connection channel 10 by the pumping activityof the heart. The first 50 and/or the second 55 plurality of projectionsmay keep the tissue of the connection channel wall structure 25 in thecircumferential groove 45 by perforating it (e.g., transfixing it, e.g.,skewering it) and/or by an interference fit. The tissue that is held inthe circumferential groove 45 may also (partially or fully) seal thetranscatheter valve prosthesis 1 against the interior of the connectionchannel 10 so that blood, e.g., pressurized blood, can only flow throughthe tubular body 30 (and the artificial heart valve 40 therein) but cannot bypass the tubular body 30 on its exterior side (i.e., between theexterior of the tubular body 30 and the interior of the connectionchannel wall structure 25). In this respect, the inner and/or outercircumferential surface of the tubular body 30 may additionally beprovided with an impermeable layer, for example in the form of a liner33 b.

The prosthesis 1 may be located in the connection channel 10 so that thecircumferential groove 45 is located on the ventricular side of theannulus of a natural valve, e.g., having a distance from the naturalvalve annulus, i.e., the circumferential groove 45 may be a sub-annularcircumferential groove and/or the prosthesis 1 may be asub-annular-prosthesis 1. The prosthesis 1 may be adapted to be asub-annular prosthesis. That is, the tubular body 30 may have atransverse dimension (also referred to as diameter herein) at an axiallevel (with respect to axis 35) that is smaller than a transversedimension of a natural valve annulus, and/or transverse dimension and/oraxial lengths of the tubular body may be suitable so that the first bodysection 31 may be located in an atrial chamber 15 and that the secondbody section 32 may be located in the connection channel 10 with thegroove 45 being located on a ventricular side of the natural valveannulus having a distance to said annulus.

Only one circumferential groove 45 as described above may be provided onthe tubular body 30. However, an elongated prosthesis 1 having two ormore circumferential grooves 45 may be provided, wherein a respectiveset of first and second pluralities of projections 50, 55 as describedabove may be arranged and assigned to the respective one of the two ormore grooves 45. The groove 45 or the respective groove may be formed bythe first and second body sections 31, 32 of the tubular body 30 assuch, wherein the projections 50 and/or 55 may or may not be involved informing the (respective) groove 45 as such. There may also beembodiments (see further below), in which the projections 50 and/or 55at least partially form the groove 45, for example on the side of thetubular body 30 that is proximal to the ventricular chamber 20.

The tubular body 30 may comprise or may be a mesh-type body havingelongate mesh or grid elements 33 (e.g., stent struts 107 and/orprojections) crossing each other at crossings 34. The mesh elements 33may be formed from wires or, for example, a laser-cut tube comprisingsteel and/or a superalloy and/or a shape memory alloy (e.g., nitinol)and/or nickel and/or titanium and/or precious metals (e.g., gold) and/oralloys comprising the aforementioned. The mesh elements 33 may alsocomprise other alloys or may be made from organic material, e.g.,polymers. The mesh elements 33 may, e.g., be made from polyvinylchlorideand/or polystyrene and/or polypropylene or another polymer. The tubularbody 30 may be from a shape-memory material which expands whenexperiencing usual body temperature. The tubular body 30 may beself-expandable. The tubular body 30 may also be not self-expandable,but expandable by a balloon or another expansion mechanism.Correspondingly, the tubular body 30 may be compressible to beinsertable via the catheter and may then be expandable whenappropriately positioned within the connection channel wall structure25. The tubular body 30 may comprise the above-mentioned liner 33 b(c.f. FIG. 6a ) attached to the mesh elements 33 made from the same ormade from different materials. The liner 33 b may be disposed on aninterior side or an exterior side of the mesh elements 33 and/or tubularbody 30 and may cover the circumference of the tubular body 30 fully oronly partially in axial direction 35 and/or in circumferentialdirection.

The circumferential groove 45 of the tubular body 30 and/or theprojections of the first and/or the second plurality of projections 50,55 may interact with the connection channel wall structure 25 so as tofix the valve prosthesis 1 with respect to the channel wall structure 25and the connection channel 10. Tissue of the channel wall structure 25may be “caught” in the circumferential groove 45 and be held in place bythe free ends 60, 65 of the first and/or the second plurality ofprojections 50, 55, which may serve as hook elements. The tissue of thechannel wall structure 25 may be perforated by the free ends 60, 65 andthereby held more firmly in the circumferential groove 45 of the tubularbody 30, wherein the tissue may also be held in the groove 45 by aninterference and/or clamping fit between the projections 50 and/or 55(or part thereof) and the tissue of the connection channel wallstructure 25. In order to allow the first and/or second plurality ofprojections 50, 55 to penetrate the tissue of the circumferentialconnection channel wall structure 25, which has been forced into thegroove, the free ends of a plurality or of each of the first 50 and/orsecond 55 pluralities of projections may be an acute or sharpened end.The projections of the first and/or second plurality of projections 50,55 each or some thereof may be pins.

With further reference to FIG. 1b , the free ends 60, 65 of the firstand/or the second plurality of projections 50, 55 may be conical ends 70so as to be able to perforate tissue of the connection channel wallstructure 25. According to embodiments, the free ends 60, 65 of thefirst and/or the second plurality of projections 50, 55 may also beblunt. The free ends 60, 65 and/or the first and/or second plurality ofprojections 50, 55 may be pin-shaped.

Some or all of the free ends 60, 65 of the projections 50,55 maycomprise barbs or hooks 71 as shown in FIG. 1a . The hooks 71 may serveto perforate tissue of the connection channel wall structure 25 andprevent the tissue from slipping off the free ends 60, 65. Therebytissue that is perforated by barbs or hooks 71 disposed on a free end60, 65 is unable to slip from the free end 60, 65 resulting in tissuefrom the heart valve connection channel wall structure 25 being caughteven more reliably in the circumferential groove 45. Some or all of thefree ends 60, 65 may be blunt or may have conical ends 70 or comprisebarbs or hooks 71. The first 50 or second 55 plurality of projectionsmay comprise different types of free ends 60, 65 according to theanatomical conditions, but may also comprise the same type of free ends60, 65.

The free ends 60, 65 and/or the first 50 and second pluralities 55 ofprojections may be arranged in different axial and/or radial positionsand orientations with respect to each other. With reference to FIGS. 1and 6 a, each projection of the first plurality of projections 50 mayhave the same circumferential angular distance a (that is an angulardistance between two radial directions extending from longitudinal axis35 of the tubular body 30) from each other, i.e. the projections 50 maybe equally circumferentially spaced. However, the projections of thefirst plurality of projections 50 may also have different angulardistances a from each other, i.e. be not spaced evenly around acircumference of the tubular body. Although not shown in FIGS. 6a-c ,similarly, each projection of the second plurality of projections 55 mayhave the same angular distance from each other, i.e. be spaced equallyaround a circumference of the tubular body 30. However, the projectionsof the second plurality of projections 55 may also have differentcircumferential angular distances a from each other, i.e. be not spacedevenly around a circumference of the tubular body.

The first plurality of projections 50 may be arranged with respect tothe second plurality of projections 55 on the tubular body 30 in a waythat each projection of the first plurality of projections 50 issubstantially on the same radial level (that is the same radius, e.g.,R2) as a projection of the second plurality of projections 55 (as it isshown e.g., in FIGS. 1 and 3). On the other hand, some or each of theprojections of the first plurality of projections 50 may be arranged ona different radius than a projection of the second plurality ofprojections 55, for example such that the first plurality of projections50 may each be on a same radius, and the second plurality of projections55 may each be on a same radius.

With, for example, reference to FIGS. 1 and 3, the first plurality ofprojections 50 and the second plurality of projections 55 may extend soas to be aligned or coaxial to each other. The first plurality ofprojections 50 may also not be aligned with the second plurality ofprojections 55. For example, the first plurality of projections 50 maythemselves extend substantially parallel to each other or may not, andthe second plurality of projections 55 may themselves extendsubstantially parallel to each other or may not.

With, for example, reference to FIGS. 2 and 4, the first and secondpluralities of projections 50, 55 may be arranged in circumferentialdirection in an alternating manner, wherein for example each firstprojection 50 is circumferentially between two second projections 55(and the other way round). There may also be other appropriatecircumferential arrangement patterns for the first and secondpluralities of projections 50, 55, wherein, for example, sets of firstprojections 50, of for example one, two, three, four, or more firstprojections 50, are arranged between sets of second projections 55, of,for example, one, two, three, four or more second projections 55.

The number of projections of the first plurality of projections 50 andthe number of projections of the second plurality of projections 55 maybe, for example, in a range of three to five, or eight to ten, fifteento twenty, thirty to one hundred or more, or may be any other number.The first plurality of projections 50 may comprise the same number ofprojections or another number of projections as the second plurality ofprojections 55 or vice versa.

The projections of the first plurality of projections 50 and/or theprojections of the second plurality of projections 55 may extend fromthe tubular body 30 from positions where mesh elements 33 of the tubularbody 30 are crossing with each other at the crossings 34. This mayimprove the mechanical stability of the interconnection of the tubularbody 30 with the projections 50, 55. The projections 50, 55 may, e.g.,be welded, soldered and/or braided to the tubular body 30. They may besutured, bonded or glued to the tubular body 30. As an alternative oradditionally, the projections 50, 55 may also be monolithicallyintegrally formed with the tubular body 30. That is, with reference to,e.g., FIGS. 9a and 9b , the projections 50,55 (or any one or both of thepluralities of projections) may be formed by mesh elements 33 that arenot connected to another mesh element 33 at a crossing 34 but areprojecting from the tubular body 30 (e.g., caused by bending the meshelement 33) in a radial and/or axial direction with respect tolongitudinal axis 35 so as to form a projection 50, 55. Further,projections 50, 55 (e.g., monolithically integrally formed by meshelements 33 or provided separately and connected with the tubular body30) may form the circumferential groove 45 by projecting radially andaxially from the tubular body 30 with respect to its longitudinal axis35. Accordingly, by facing away from the tubular body 30, theprojections may define a circumferential groove 45 on the tubular body30. The circumferential groove 45 may be further defined by a generallyconical or similar shape of a body section (e.g., first body section 31and or second body section 32) of the tubular body 30 that has across-sectional diameter that is increasing from the groove 45 in adirection of longitudinal axis 35. As seen e.g., in FIGS. 9a and 9b ,the generally conical shape of a body section 31, 32 may accordinglyinteract with the projections 50, 55 which are projecting from thetubular body 30 so as to further define the circumferential groove 45.FIG. 9a shows projections 50, 55 that define a circumferential groove 45by projecting first in a substantially radial direction relative to thelongitudinal axis 35 and then in a substantially parallel direction tothe longitudinal axis 35 when seen from the point from which theprojections extend from tubular body 30. FIG. 9b shows projections 50,55 that extend generally rectilinearly to define the circumferentialgroove 45. The projections 50, 55 may be made from the same materialsthat were described above with reference to the tubular body 30, e.g.,super alloys, e.g., shape memory alloys (like nitinol) or steel ortitanium (or alloys comprising titanium) or organic material likepolymers, or the projections may be made from different material ormaterials.

In embodiments, the first end 67 of the first plurality of projections50 and/or the second plurality of projections 55 may include one or morefirst apertures 105 substantially aligned with second apertures disposedbetween stent struts 107 of the tubular body 30 (FIGS. 13a and 13b ).The first apertures 105 may include various configurations including,for example, square, circular, and triangular. Additionally, the firstapertures 105 may be larger than, smaller than, or of approximatelyequal size to the second apertures disposed between the stent struts107. The second end 69 of the first plurality of projections and/or thesecond plurality of projections 55 may also include a matchcircumferential curvature of stent surface that does not include anaperture. In the embodiment of FIGS. 13a and 13b , the second ends 69form substantially flat ends 166 and extend in a direction parallel to atangent of the tubular body 30, and therefore second ends 69 areconfigured so as not to cause trauma to the surrounding tissue (e.g.,Tangent T, as indicated on FIGS. 13a and 13b ).

As discussed above, in embodiments, the first plurality of projections50 and/or the second plurality of projections 55 may include blunt endsconfigured not to penetrate the tissue. For example, the struts 110 mayeach include a first strut 113 and a second strut 115 joined throughconnector 117. As shown in FIG. 14, for example, the first struts 113,the second struts 115, and the connector 117 together may form roundedtriangle configurations. In alternate embodiments, the struts 110 maycomprise various configurations, for example, rectangular, rounded,elliptical, or a combination of these configurations, for example, theplanar projection shown in FIGS. 13a and 13b . In the embodiment ofFIGS. 13a and 13b , for example, each connector 17 forms substantiallyflat end 166. Additionally, the struts 110 may include asymmetricaland/or irregular configurations. For example, as shown in FIG. 19, firststruts 113 may not be symmetrical with second struts 115 such that thefirst and second struts 113, 115 each include random and differentconfigurations. Furthermore, each connector 117 may include an irregularshape. In some embodiments, each first strut 113 may have aconfiguration similar to the other first struts 113, each second strut117 may have a configuration similar to the other second struts 117, andeach connector 117 may have a configuration similar to the otherconnectors 117, but each first strut 113 may have a configurationdifferent from each second strut 115.

As can be seen e.g., from FIG. 8, all or some projections of the firstplurality of projections 50 and/or all or some projections of the secondplurality of projections 55 may extend in (e.g., along) a substantiallystraight line or in a straight line, i.e., they may not comprise anylongitudinal curvature from the point from which they extend from thetubular body 30 to their respective free end 60, 65; i.e., they mayextend rectilinearly. They may, however, nevertheless comprise barbs orhooks 71 and or may be pin-shaped. The first plurality of projections 50may extend from substantially the same axial level (relating to theaxial direction of the tubular body 30) from the tubular body 30 (e.g.,shown in FIGS. 1 to 3) or may extend from different axial levels fromthe tubular body 30. Correspondingly, the second plurality ofprojections 55 may extend from substantially the same axial level(relating to the axial direction of the tubular body 30) from thetubular body 30 (e.g., shown in FIGS. 1 to 3) or may extend fromdifferent axial levels from the tubular body 30. The axial extension ofthe first plurality of projections 50 (axial distance (along axis 35 oftubular body 30) between base of projection on the tubular body and freeend of projection) and/or of the second plurality of projections 55 maybe substantially the same or may be different, and the extension orlength of the first plurality of projections 50 and/or of the secondplurality of projections 55 (distance between bases of the projections50, 55 on the tubular body 30 and the free ends 60, 65 of theprojections 50, 55) may be the same or may be different.

In addition to the first and second plurality of projections 50, 55, thetubular body 30 may be provided with any other type of projection and/orcollar.

The first 50 and the second 55 pluralities of projections may extendfrom the first 31 and the second 32 body sections, respectively, fromareas that are adjacent to or are bordering the radially outercircumference of the circumferential groove 45. The first 50 and thesecond 55 pluralities of projections may extend from the opposite sidewalls 48, 49 laterally defining the groove 45.

Referring to FIG. 2, the free ends 60 of the first 50 plurality ofprojections may be axially spaced from the free ends 65 of the second 55plurality of projections by an axial distance W2 in a direction of theaxis 35 of the tubular body 30. The free ends 60 of the first pluralityof projections 50 may be arranged on a same axial level or on differentaxial levels, and the free ends 65 of the second plurality ofprojections 55 may be arranged on a same axial level or on differentaxial levels.

In case a transcatheter valve prosthesis 1 comprises a plurality ofprojections 50, 55, the axial distance W2 may define a distance of oneor more or all of the free ends 60, 65 of the (one) plurality ofprojections 50, 55 to a sidewall 48, 49, that is opposite to therespective body section 31, 32 from which the plurality of projectionsextends, of the circumferential groove 45.

The projections of the first plurality of projections 50 may axiallyoverlap with the projections of the second plurality of projections 55(not shown), wherein there may be defined an axial overlapping-distancebetween the free ends 60 of the first plurality of projections 50 andthe free ends 65 of the second plurality of projections 55. Some freeends 60 of the first plurality of projections 50 may be axially spacedfrom corresponding free ends 65 of the second plurality of projections55, while other free ends 60 and 65 may be arranged so as to axiallyoverlap each other.

With reference, for example, to FIG. 2a , the projections 50, 55 (each)may extend in a manner so as to be radially and inwardly inclined by anangle β, thereby obliquely extending into the outer circumferentialgroove 45. The angle β defining the radial and inward inclination of theprojections 50, 55 with respect to the axis 35 of the tubular body 30may be an acute angle, for example in a range of equal to or smallerthan 45° or equal to or smaller than 30°, or equal to or smaller than15°. Only a part or number of the first projections 50 and/or only apart or number of the second projections 55 may radially and inwardlyinclined as above described.

FIG. 6a , which corresponds to the cross section along A-A shown in FIG.3, illustrates the interaction of heart valve tissue of the connectionchannel wall structure 25 and the first plurality of projections 50 (across-section transverse the axis 35 and through the second plurality ofprojections 55 would result in a similar depiction to that shown in FIG.6a ). The first plurality of projections 50 can be seen perforatingtissue of the connection channel wall structure 25 to thereby morereliably prevent it from retracting from the tubular body 30 of theprosthesis 1, which results in the prosthesis 1 being held more firmlyin its intended place.

With further reference to FIG. 3 and FIG. 6b , the transcatheteratrioventricular valve prosthesis 1 may further comprise an elongateouter member 75. The elongate outer member 75 may be disposed at theexterior of the connection channel wall structure 25 (e.g., in theventricular chamber 20) at an axial level (e.g., with respect to axis35) of the circumferential groove 45 of the tubular body 30. Theelongate outer member 75 may extend at least partially around, forexample completely and continuously circumferentially around, thetubular body 30 and may be handled e.g., using a catheter member 90 thatis shown schematically in FIG. 6b . A radial distance R5 between thelongitudinal axis 35 and the elongate outer member 75 may be reducibleor reduced so that the valve tissue of the connection channel wallstructure 25 can be correspondingly at least partially forced into theouter circumferential groove 45 so as to be at least partially locatedradially below the first and second pluralities of projections 50, 55.The radial distance R5 may be reducible or reduced so that it is smallerthan a radial distance R4 that is defined between the longitudinal axis35 of the tubular body 30 and the free ends 60, 65 of the projections50, 55 (the free ends 60, 65 are not visible in the cross section shownin FIG. 6b , but they are indicated by crosses in FIG. 6b ). Thus, theelongate outer member 75 may be positioned inside the circumferencedefined by the first and second pluralities of projections 50, 55 sothat tissue of the connection channel wall structure 25 is or can belocated in the circumferential groove 45 between the groove bottom 46and the first and second projections 50, 55, wherein the elongate outermember 75 itself may be located inside the groove 45 between the groovebottom 46 and the first and second pluralities of projections 50, 55.However, the elongate outer member 75 may also be arranged to forcetissue of the connection channel wall structure 25 into thecircumferential groove 45 but to remain outside the groove (i.e. R5 maybe larger than R4 as shown in FIG. 6b ). The catheter member 90, oranother, for example similarly structured catheter device, may be usedto handle and position the elongate outer member 75 around an exteriorof the circumferential connection channel wall structure 25.

With further reference to FIGS. 6b and 7, the catheter member 90 maycomprise a connector 91, for example a cutting and clamping member, thatcan be used to connect free ends of the elongate member 75, for exampleto cut the elongate outer member 75 and clamp two ends of it together,so that the elongate member 75 may remain permanently around the tubularbody 30 and thereby form a component of the prosthesis 1. However, theelongate outer member 75 may also merely be an interventional tool, forexample as a component of catheter member, and may only be used toradially force the tissue of the connection channel wall structure 25into the outer groove 45, and may then be withdrawn or removed from theheart. When the elongate member 75 remains permanently positioned aroundan outer side of the connection channel wall structure 25, it maypermanently apply a radial and inwardly, axially, or outwardly directedforce to the tissue of the connection channel wall structure 25 towardsthe groove 45.

With reference to FIGS. 1, 3, 6 b and 7, there may be several ways inwhich heart tissue of the connection channel wall structure 25 is fixed,held and/or caught in the circumferential groove 45. The tissue may beperforated by the free ends 60, 65 of the first and/or the secondplurality of projections 50, 55, e.g., via the acute ends 70 and/or thebarbs or hooks 71. The tissue may be held in the circumferential groove45 by an interference fit between the projections 50, 55. The tissue mayalso be held in the circumferential groove 45 by the elongate outermember 75. The elongate outer member 75 may be used to force the tissueinto the groove 45 either temporarily (e.g., as a method step during aheart treatment) or permanently (for example, if the cutting andclamping member 91 is used to cut elongate outer member 75 and toconnect its two ends together permanently while it is extending aroundthe exterior of the connection channel wall structure 25 as shown inFIG. 7). The tissue of the connection channel wall structure 25 may alsobe held in the circumferential groove 45 by a combination of two or moreof the above described approaches.

In embodiments, the elongate outer member 75 may have a cross-sectionaldiameter D1 (see e.g., FIG. 6b ) that is smaller than a width W1 of theouter circumferential groove 45 (illustrated e.g., in FIG. 2). Theelongate member 75 may have a cross-sectional diameter D1 that issmaller than the gap W2 between the free ends 60, 65 of the first andthe second plurality of projections 50, 55. The elongate member 75 mayhave a cross-sectional diameter D1 that is larger than width W2 butsmaller than width W1. The elongate member 75 may have a cross-sectionaldiameter D1 that is larger than width W2 and/or width W1. The elongatemember 75 may be a wire or a band, and may have a circular cross sectionor a rectangular cross section. The elongate member 75 may also have atriangular cross section or a cross section defining any other curved orpolygonal shape. The elongate member 75 may be made from any materialthat has been described with reference to the mesh elements 33 or acombination of those materials or other material(s). For example, theelongate member may be made from steel, a titanium alloy or a shapememory alloy such as nitinol.

A length of the projections 50 and/or 55 may be related to the width W1of the circumferential groove 45. In this respect, the ratio of adistance between the free ends 60, 65 of the first and secondpluralities of projections 50, 55 (or, if only one plurality ofprojections 50, 55 is provided, a distance of the free ends 60, 65 ofthat plurality of projections 50, 55 to the sidewall 48, 49 of thecircumferential groove 45 that is with respect to axis 35 opposite tothe projections 50, 55) to the width W1 of the circumferential groove 45may have a maximum value of 0.5 or 0.4 or 0.3 or 0.2 or 0.1. Accordinglythe hollow chamber 66 may be defined between the projections 50, 55 andthe groove bottom 46. The width W1 of the circumferential groove 45 maybe defined between the sidewalls 48, 49 of the groove 45 and or betweena point from which a projection 50, 55 of the first and/or secondplurality of projections 50, 55 extends from the tubular body 30 and asidewall 48, 49 that is located on an opposite side of the groove (45)and/or between a point from which a projection from the first pluralityof projections 50 extends and a point from which a projection form thesecond plurality of projections 55 extends.

With reference to FIGS. 4 and 5 (for improved clarity and understanding,the transcatheter valve prosthesis 1 is shown without artificial valve40), the transcatheter valve prosthesis 1 may also comprise a clampingmember 80. The clamping member 80 may comprise a tubular structurehaving a longitudinal axis that may be arranged so as to extend in thecircumferential groove 45 in a circumferential direction of the tubularbody 30. The clamping member 80 may be located in the circumferentialgroove 45 so as to be located (for example at least partly) radiallyinwards of the first and second pluralities 50, 55 of projections. Theclamping member 80 may be in contact with the groove bottom 46 of thecircumferential groove 45. The clamping member 80 may extend around awhole circumference of the tubular body 30 or only partially around thetubular body 30, as shown, e.g., in FIGS. 4 and 5. The clamping member80 may extend, e.g., around an angle of 10 to 30 degrees or any otherangle in the circumferential groove 45. The clamping member 80 mayextend around the whole circumference of groove 45, e.g., around 360degrees. The clamping member 80 may have a cross-sectional diameter D2transverse to its longitudinal axis. The cross-sectional diameter D2 maybe selectively changeable to a larger or smaller diameter D2; i.e., theclamping member 80 may be compressible (so as to be insertable via acatheter) and/or expandable (for example, re-expandable after beingcompressed) in a radial direction of its diameter D2, whereby the innerand outer circumferences of the clamping member are correspondinglydecreased/expanded and expanded/decreased, respectively, in a radialdirection of the tubular body 30 towards the first and/or the secondplurality of projections 50, 55. The cross sectional diameter D2 of theclamping member 80 may be smaller than the cross sectional diameter(radius R1 is shown, e.g., in FIG. 6a ) of the tubular body 30. Inembodiments, the diameter D2 of the clamping member 80 may be smallerthan the width W1 of the outer circumferential groove 45 and smallerthan the width W2 of the gap formed between the free ends 60, 65 of thefirst and the second plurality of projections 50, 55. The clampingmember 80 may be provided in order to clamp heart tissue that is locatedinside the circumferential groove 45 outwards in a direction from theaxis 35 towards the pluralities of projections 50, 55.

The clamping member 80 may include a delivery configuration within adelivery catheter and a deployment configuration wherein the clampingmember 80 is deployed from the delivery catheter. In embodiments, theclamping member 80 may be biased to the deployment configuration. Forexample, the clamping member 80 may include a shape-memory alloy such asa nitinol or a nitinol-based alloy that has a delivery configurationthat is shaped to be convenient for delivery through a catheter, and adeployment configuration in which the shape-memory alloy changes shapeto a deployed configuration so as to be biased to a shape conforming tothe tubular body.

With reference to FIG. 6d , the clamping member 80 may be or form partof the above-described elongate outer member 75, wherein the clampingmember 80 may be arranged and or guided and/or positioned (in a radiallycompressed condition) at the circumferential outer side of theconnection channel wall structure 25 to completely or partly extendaround the connection channel wall structure 25 at an axial (withrespect to the axis 35 of the tubular body 30) level, and may then beradially expanded (in a direction of the diameter D2 of the clampingmember 80), whereby its inner diameter in a radial direction of thetubular member 30 then correspondingly decreases to thereby force thetissue of the inwardly arranged connection channel wall structure 25(which is then arranged inwards of the clamping member 80) radially intothe groove 45. That is, the clamping member may be located between theprojections 50, 55 and tissue of the connection channel wall structure25, that may be pressed into the groove 45 by an elastic force exertedby the clamping member 80 on the tissue of the connection channel wallstructure 25 and a corresponding reactive force that may be exerted bythe clamping member 80 on the projections 50, 55. The forces that mayact upon the tissue of the connection channel wall structure 25 exertedby the clamping member 80 and the groove 45 (e.g., the groove bottom 46)are schematically indicated by arrows 85 b. The elongate outer member 75and/or the clamping member 80 (which may be the same member) may serveto anchor the prosthesis 1 and to seal the native heart leaflets againstthe prosthesis 1 against blood flow. Further, immobilization of thenative leaflets by the prosthesis 1 as described herein (e.g.,comprising a clamping member 80 and/or elongate member 75) may favor theingrowth of heart (e.g., leaflet) tissue into the prosthesis (e.g.,circumferential groove 45) and thereby further improve fixation of theprosthesis 1 relative to the heart and/or sealing against blood flow asthe ingrown tissue may additionally or alternatively seal against bloodflow on an outside of the tubular body 30.

In some embodiments, the clamping member 80 may include one or morebarbs 230 configured to secure the prosthesis 1 to portions of thenative valve leaflets and/or chords when the barbs 230 are deployed, forexample, by piercing the portions of native valve leaflets and/or barbs.For example, as shown in FIG. 20, the clamping member 80 may include aninner member 210 slideably disposed within a hollow outer tube 200. Itis further contemplated that the outer tube 200 may be slideablydisposed with regard to the inner member 210. One or more flexibleregions 240 may be disposed on the outer tube 200 to facilitate bendingof the clamping member 80. The flexible regions 240 may include cutouts,for example as shown in FIG. 20, or may include material sufficient tofacilitate such bending of the clamping member 80. The cutouts may be ofvarious shape and sizes. Additionally, the flexible regions 240 may bedisposed consistently or intermittently on outer tube 200.

One or more openings 220 may be disposed through an outer surface of theouter tube 200, such that the openings 220 are coupled with one orebarbs 230 on the inner member 210. For example, the barbs 230 may eachbe configured to assume a first delivery configuration wherein the barbs230 are disposed substantially parallel to the inner member 210 and aredisposed within the outer tube 200. For example, the barbs 230 may laysubstantially flat along the inner member 210. Movement of the innermember 210 relative to the outer tube 200 may substantially align thebarbs 230 with the openings 220 such that the barbs 230 move from thefirst delivery configuration to a second deployment configuration. Forexample, as shown in FIG. 22, the barbs 230 may extend away from theclamping member 80, and may be configured to attach to the nativeleaflets and/or chords. Therefore, the barbs 230 may be deployed throughthe openings 220 when in the deployment configuration.

Various means may be used to deploy the barbs 230 from their deliveryconfiguration to their deployment configuration. For example, the barbs230 may be comprised of a superelastic material such that theyimmediately assume the deployment configuration once aligned withopenings 220. In other embodiments, the barbs 230 may be moved into thedeployment configuration through a hydraulic force (for example, by theinflation of a balloon), pushing of the barbs 230, rotating of the barbs230, a spring mechanism, and/or thermal electric current.

The barbs 230 may be deployed, and assume the deployment configuration,before the tubular body 30 is fully deployed. For example, the barbs 230may be deployed when the tubular body 30 is partially deployed.Alternatively, the barbs 230 may be deployed after the tubular body 30is fully deployed.

The delivery configuration of the barbs 230 may be substantiallyperpendicular to the deployment configuration of the barbs 230.Additionally, the barbs 230 may be arcuate when in the deploymentconfiguration, for example as shown in FIGS. 21 and 23. It is furthercontemplated that the barbs 230 may constitute a helical structureconfigured to be driven into the connection channel wall structure 25when the barb is rotated about its longitudinal axis (FIG. 27). Thehelical structure may pierce adjacent native leaflets and/or chords(e.g. a first portion and a second portion) to secure the adjacentnative leaflets and/or chords together, as shown in FIG. 27. The helicalstructure may include a helical needle. In some embodiments, a suturemay be advanced from the helical needle to secure the adjacent nativeleaflets and/or chords together.

In some embodiments, the clamping member 80 may include a first set ofbarbs 233 configured to be oriented toward an inflow side of thecircumferential groove 45 when the clamping member 80 at least partiallyencircles the circumferential groove 45, as shown in FIG. 26.Additionally or alternatively, the clamping member 80 may include asecond set of barbs 235 configured to be oriented toward an outflow sideof the circumferential groove 45 when the clamping member 80 at leastpartially encircles the circumferential groove 45.

The inner member 210 may include one or more slits 250 on an outersurface of the inner member 210. Each barb 230 may be disposed within aslit 250 when the barb 230 is in the delivery configuration. Therefore,the inner member 210 may be configured to slide within the outer tube200 without interference from the barbs 230. Additionally oralternatively, the inner member 210 and/or the outer tube 200 may becoated with a lubricious coating to facilitate the sliding of the innermember 210 relative to the outer tube 200.

A pusher tube 260 may be configured to push and/or pull the inner member210 in a longitudinal direction of or rotationally relative to the outertube 200 to deploy the barbs 230. It is also contemplated that thepusher tube 260 may be configured to push and/or pull the outer tube 200in a longitudinal direction of or rotationally to the inner member 210to deploy the barbs 230. As shown in FIGS. 25a-25c , for example, thepusher tube 230 may be releasably attached to the inner member 210through connection 270. In some embodiments, the connection 270 mayinclude a first connection link 280 on the pusher tube 260 that isreleasably coupled to a second connection link 290 on the pusher tube260. Therefore, the pusher tube 260 may selectively push and/or pull theclamping member 80 when the first connection link 280 is attached to thesecond connection link 290 to align the barbs 230 with openings 200 todeploy the barbs 230. Additionally, the pusher tube 260 may beselectively released from the inner member 210. In some embodiments, thepusher tube 260 may be advanced over the elongate outer member 75 todeploy the barbs 230. For example, the pusher tube 260 may be connectedto inner member 210 through connection 270 and advanced over theelongate outer member 75 with the clamping member 80.

The barbs 230 may be configured to attach to the projections 50 and/or55 to secure the prosthesis 1 to the portions of native valve leafletsand/or chords. For example, as shown in FIGS. 26 and 27, the first setof barbs 233 may be disposed through projections 55 and the second setof barbs 235 may be disposed through projections 50. As shown in FIGS.26 and 27, the shape of the barbs 230 secures the barbs 230 to theprojections 50, 55. It is further contemplated that other well-knownattachment means may be used to secure the barbs 230 to the projections50, 50, for example, including but not limited to, sutures, adhesive,clamps, etc.

The circumferential opening of the groove 45 may be defined by an indentin a side surface of the tubular body 30, and the groove 45 may belarger than a maximum outer diameter of the clamping member 80, as shownin FIGS. 26 and 27. Therefore, the attachment of the barbs 230 to theportions of native valve leaflets and/or chords may secure theprosthesis 1 to the portions of native valve leaflets and/or chords.Withdrawal of the barbs 230 away from and out of the portions of nativeleaflets and/or chords may thus cause the prosthesis 1 to no longer besecured to the portions of native valve leaflets and/or chords.

In embodiments, when partially deployed, such that the outflow end butnot the inflow end is deployed from a delivery catheter, the tubularbody 30 may form a frustoconical shape that slopes radially outward fromthe circumferential groove 45 and toward the outflow end. For example,the tubular body 30 may slope radially outward approximately 2°-45° withregard to a longitudinal center axis of the tubular body 30 whenpartially deployed. In embodiments, the tubular body 30 may slopeapproximately 5°-30°, or approximately 10°-20°, or approximately 15°with regard to the longitudinal center axis of the tubular body.

In the partially deployed state, the elongate outer member 75 maybe slidalong the tubular body 30 to guide tissue of wall structure 25 (e.g.,native valve leaflets and/or chords) into the circumferential groove 45.For example, the elongate outer member 75 may slide in a directionmoving radially inward along the slope of the tubular body 30 from anoutflow end of the tubular body toward an inflow end of the tubular body30 and into circumferential groove 45. When sliding along thefrustoconical shape of the partially deployed tubular body 30, theelongate outer member 75 may be disposed outside the wall structure 25and therefore slide along the tubular body 30 and along the wallstructure 25. Therefore, elongate outer member 75 may move the nativevalve leaflets and/or chords of the wall structure 25 into thecircumferential groove 45 such that the native valve leaflets and/orchords are disposed between the tubular body 30 and elongate outermember 75 (FIG. 10c ). This may trap the native valve leaflets and/orchords within the circumferential groove 45.

FIG. 6c shows a schematic cross sectional view of the tubular body 30and the clamping member 80 similar to the cross section C-C in FIG. 4,however additionally showing heart tissue of the connection channel wallstructure 25 that is not shown in FIG. 4. In FIG. 6c , the positions ofthe first or second pluralities of projections 50, 55 are indicated bydots 50, 55. As can be seen from FIG. 6c , the heart tissue of theconnection channel wall structure 25 is located inside thecircumferential groove 45 radially between the groove bottom 46 of thetubular body 30 and a diameter that is defined by the free ends 60, 65of the first and/or the second plurality of projections 50, 55. It canbe seen from FIG. 6c that the clamping member 80 is elastically strainedby the tissue of the connection channel wall structure 25 and in turnexerts a force that presses the tissue of the connection channel wallstructure 25 against the free ends 60, 65. Arrows 85 indicate the forcesthat are caused by the clamping member 80 and that act upon the tissueof the connection channel wall structure 25 in the groove 45.

With reference, e.g., to FIGS. 6c and 6d , which show only one clampingmember 80, there may also, e.g., be two or more clamping members 80arranged in the groove 45 which are arranged in parallel to each otherand/or which are arranged sequentially in a circumferential direction,with for example a circumferential distance therebetween or abuttingeach other, of the tubular body 30. For example, there may be twoclamping members 80 abutting each other and a third clamping member 80that has an angular distance from the two clamping members 80 that areabutting each other may also be arranged in the groove 45. Clampingmembers 80 may, e.g., be positioned on diametrically opposite sides ofthe groove 45. These two or more (e.g., 3 to 5) clamping members 80 mayall have the same cross-sectional diameter D2 or may each have differentcross-sectional diameters. The clamping members 80 may all have the samelongitudinal length or may have different longitudinal lengths (e.g., ina circumferential direction of tubular body 30). Clamping members 80 maybe designed and arranged so that the tubular body 30 is firmly held inplace according to the specific tissue structure and conditions of theconnection channel wall structure 25 of a specific heart (e.g., of apatient). They may, e.g., be specifically chosen and arranged by anoperator or surgeon to firmly hold the tubular body 30 in placeaccording to local conditions. The respective clamping member 80 mayhave a shape other than a tubular shape, such as a block-shape, acubic-shape or a ball-shape.

The force acting on the tissue of the connection channel wall structure25 may be increased when the clamping member 80 is used together withthe elongate outer member 75, thereby further improving the connectionbetween the transcatheter valve prosthesis 1 and the connection channelwall structure 25. In this case, an elastic force originating from theclamping member 80 pointing from the axis 35 outwards, and a forceoriginating from the elongate outer member 75 pointing inwards to theaxis 35, act upon tissue of the connection channel wall structure 25,thereby holding the prosthesis 1 firmly in its intended position in theconnection channel 10. However, the valve prosthesis 1 may be usedwithout the clamping member 80 and the elongate outer member 75 as well(i.e., by itself), or together with only one (any one) of them. Aprosthesis 1 not comprising a plurality of projections 50, 55 may befixed by clamping member 80 and/or elongate outer member 75, e.g., whenthe elongate outer member 75 and/or the clamping member 80 are/isgenerally rigid, e.g., when comprising or being an inflatable balloonthat is filled with a substance giving it rigidity caused by a pressureor by a curing of that substance. If present, that substance can curewithin a limited amount of time, with the injection of an additionalagent (e.g., a reticulating agent), with application of heat or energy.It can be, for example, PMMA (Poly Methyl Methacrylate), differentepoxies, polyurethane, or a blend of polyurethane silicone. It can bestrengthened, for example with the addition of reinforcement fibers(e.g., polyaramid such as Kevlar®, carbon).

Clamping member 80 may be made from a mesh-type structure as shown inFIGS. 4 and 5 and may comprise an inner lumen. The mesh may be made frommetal or organic material or other material. The mesh of clamping member80 may be made, e.g., from iron, nickel, aluminum and/or titanium and/oralloys of these metals and other elements. The mesh may be made, e.g.,from steel (e.g., spring steel), and/or a superalloy and/or shape memoryalloy (such as, e.g., nitinol), Ti₆Al₄V, and/or a precious metal likegold, or any combination of those and/or other materials. The mesh ofclamping member 80 may also be made from polymers, e.g., frompolypropylene or polyvinylchloride, polyethylene or nylon. Of course,the mesh may also be made from combinations of these materials, i.e., itmay be made from two or more different materials. In embodiments, theclamping member can be an expandable stent-graft made with a steel ornitinol stent covered with a polyester or PTE (polyethyleneterephthalate) graft material, such as Dacron®, or an ePTFE (expandedPoly Tetra Fluoro Ethylene) graft material. The mesh of clamping member80 may also or additionally comprise any material that has beendescribed with reference to the mesh elements 33 of the tubular body 30and/or with reference to the elongate member 75, and the clamping member80 may be designed and a material for it may be chosen so as to create ahigh elastic force to press the tissue of the connection channel wallstructure 25 against the projections 50, 55. Clamping member 80 may beprovided with hooks or barbs to create an attachment to tubular body 30.

Clamping member 80 and/or elongate outer member 75 may comprise aninflatable inner member (not shown). The inflatable inner member may bedisposed in an inner lumen of the clamping member 80 and may be inflatedso as to increase diameter D2 of clamping member 80, thereby pressingtissue of the connection channel wall structure 25 against theprojections 50, 55 (either from an inner side if the clamping member 80is arranged in the hollow chamber 66 or from an outer side if theclamping member 80 is arranged at an outer side of the connectionchannel wall structure 25). The inner member may be inflated by theoperator using a tubing and fluid (gas or liquid) from an externalpressure source, e.g., a syringe, a fluid bottle or a pump locatedoutside the body. The clamping member 80 may be an inflatable member 80that presses tissue of the connection channel wall structure 25 againstthe projections 55, 55 when inflated. Both the inflatable inner memberand the inflatable member 80 may be made from a fluid tight, pressureresistant material, e.g., a material or polymer as described above withreference to the clamping member 80, or any other suitable material.With reference to, e.g., 11 a-11 b, the inflatable member may comprisean aperture 76 (e.g., a valve, e.g., an opening) through which asubstance (e.g., via a delivery tube (not shown)) may be delivered intothe inflatable member and/or out of the inflatable member. The aperture76 may selectively permit the transmission of a substance (i.e., have an“open-state”) or may block the transmission of a substance (i.e., have a“closed-state”). The aperture 76 may serve to fill the inflatable memberor to un-fill (e.g., to empty) the inflatable member in order to changea cross-sectional diameter of the inflatable member. The clamping member80 and/or the elongate outer member 75 may be made of an elasticmaterial (e.g., a polymer and/or a metal) and/or may be filled with acompressible (e.g., elastic) substance (e.g., a gas and/or a foammaterial and/or a hydrogel) to provide a damping/cushioningfunctionality. A substance for filling the inflatable member may be agas, a liquid or any other substance and/or may be a substance thatchanges its phase (e.g., gas, liquid, solid) when in the inflatablemember (the substance may, e.g., change from liquid phase to a generallysolid phase). The substance may be a substance that is capable of curingand/or hardening when disposed in the inflatable member so as to providea generally rigid clamping member 80 and/or elongate outer member 75.

Clamping member 80 may apply a force to the opposite side walls 48, 49of groove 45, for instance upon radial expansion relative to itslongitudinal axis. This force may increase or decrease the distancebetween body sections 31 and 32 and/or the distance between axial ends(with respect to axis 35) of the tubular body 30. Tubular body 30 may bemade to be elastic (e.g., comprising a mesh structure and/or an elasticmaterial). The force exerted by clamping member 80 may result in anexpansion or reduction of a perimeter of the groove bottom 46 along acircumference of groove 45 and/or in an expansion or reduction ofdiameter R1 of the tubular body 30 at an axial height (with respect toaxis 35) of groove 45 respectively. The clamping member 80 and/or theelongate outer member 75 (which may be the same member or may beseparate members) may also not produce a force in a radial directionand/or a longitudinal direction of the tubular body 30 with respect toits longitudinal axis 35. Accordingly, the clamping member 80 and/or theelongate outer member 75 may act as a displacement member by displacingtissue of the connection channel 10 without exerting a clamping force tothe tubular body 30 but by providing a mere interference fit between thecircumferential wall structure 25 of the connection channel 10, theclamping member 80 and/or the tubular body 30 in addition or as analternative to, e.g., tissue being pierced by projections of the first50 and/or second plurality of projections 55.

The clamping member 80 and/or elongate outer member 75 may be locatedonly partially radially inwards of the first 50 and/or second 55plurality of projections and may be located so as to be pierced by anyone or both pluralities of projections 50 so as to be held relative tothe tubular body 30. The elongate outer member 75 and/or clamping member80 may be pierced by only one plurality of projections 50, 55 and theother plurality of projections may not pierce the clamping member80/elongate outer member 75 (or, the other plurality of projections maynot be provided in case of a prosthesis 1 only comprising one pluralityof projections (on one side of the groove 45)). The plurality ofprojections 50 and/or 55 may pierce the clamping member 80 so that therespective free ends 60, 65 of the projections 50, 55 end inside theclamping member 80 or so that the free ends 60, 65 of the respectiveprojections 50, 55 penetrate through the clamping member 80 and exitfrom the clamping member so that the respective free ends 60, 65 may belocated outside the clamping member 80.

With reference to FIG. 10b , the elongate outer member 75 and/or theclamping member 80 may be provided in the groove 45 radially inwards ofthe projections 50, 55 so that the elongate outer member 75 and/or theclamping member 80 is not pierced by the projections 50, 55. Inembodiments, the clamping member 80 may trap at least portions of nativevalve leaflets and/or chords within the circumferential groove 45defined by the tubular body 30 and the first plurality of projections 50and/or the second plurality of projections 55. For example, the nativevalve leaflets and/or chords may be disposed between the clamping member80 and the second plurality of projections 55 within circumferentialgroove 45. The elongate outer member 75/clamping member 80 may be heldby a mere interference fit or a frictional/interference fit between thegroove 45, the tissue of the connection channel wall structure 25 and orprojections 50, 55 in the groove 45 (e.g., when inflated, e.g., whenexpanded). Further, as schematically shown in FIG. 10b , the elongateouter member 75/clamping member 80 may have a cross sectional shape thatis substantially elliptical or has any other shape, such as atriangular, rectangular or polygonal shape. The substantially ellipticalshape of the elongate outer member 75/clamping member 80 that is shownin FIG. 10b may be caused by the design of the elongate outer member75/clamping member 80, e.g., when it is provided with a tubularstructure having a substantially elliptical shape (e.g., when expanded),or it may be caused by anisotropic forces acting upon elongate outermember 75/clamping member 80 caused, e.g., by the projections 50, 55,the tissue of the circumferential wall structure 25 and/or groove 45.That is, the elongate outer member 75/clamping member 80 may have asubstantially round cross section when no external forces act upon itand may assume a different shape (e.g., elliptical), when implanted(and, e.g., expanded).

With reference to, e.g., FIG. 10c , an expandable and or reducibleelongate outer member 75 (e.g., clamping member 80) may have a diameterD2 that may be larger than width W1 of circumferential groove 45 whenexpanded so that the elongate outer member 75 may extend out of thegroove 45 and may occupy a space between the circumferential wallstructure 25 and tissue forming a heart chamber (e.g., the ventricularchamber 20 and/or atrial chamber 15), i.e., the elongate outer member 75may form a shape arranged between (e.g., abutting) the connectionchannel wall structure 25 and tissue/muscles of a heart chamber wall(e.g., of ventricular chamber 20) when expanded (e.g., fully expanded).Accordingly, the elongate outer member 75 may be located (e.g.,partially, e.g., a part thereof) radially outside (with respect to axis35) the circumferential groove 45 and may extend parallel to axis 35along one or both body sections 31, 32 (e.g., along second body section32) of tubular body 30 while being (e.g., partially, e.g., a part ofelongate outer member 75) located radially outside groove 45.Accordingly, the elongate member 75 may comprise an angularly shaped(e.g., substantially describing an angle of about 90°) cross sectionwith a first angular leg 75 a that may extend with respect to axis 35generally radially into the groove 45, and a second angular leg 75 b matmay extend generally parallel to axis 35 of the tubular body 30 on anoutside of the tubular body 30 (e.g., along first body section 31 and/orsecond body section 32). That is, the elongate outer member 75 (e.g.,second angular leg 75 b thereof) may be disposed between the first 31and/or second 32 body section and tissue/muscle forming a wall of aheart chamber such as the ventricular chamber 20 and/or atrial chamber15. While in FIG. 10a-c the elongate outer member 75/clamping member 80is only shown on one side of the prosthesis 1, it may also extend fullyor partially (as shown, e.g., in FIG. 11a-d ) around the prosthesis 1(e.g., the circumferential groove 45). The elongate outer member75/clamping member 80 may comprise free ends 77, 78 (e.g., two free ends77, 78) in a direction of a central-longitudinal axis that may benon-connected and/or not abutting each other, i.e., spaced away fromeach other. The free ends 77, 78 may have an angular distance from eachother (e.g., in the groove 45, e.g., when inflated in the groove 45)defined by an angle of, e.g., less than 180°, less than 90°, less than45° or less than 10° with respect to axis 35. The aperture 76 may beprovided on one of these free ends 77, 78 or an aperture 76 may beprovided on each of the free ends 77, 78. When the elongate outer member75/clamping member 80 only extends partially around circumferentialgroove 45 and accordingly comprises free ends, it may have a rigiditycaused by a substance, e.g., by a curing substance (that may be cured).

A shown in FIGS. 15a, 15b, and 15c , the clamping member 80 may beguided over the elongate outer member 75 and into the circumferentialgroove by an insertion member 130. For example, insertion member 130 maybe connected to clamping member 80 with a releasable coupling member133. The insertion member 130 may be configured to push the clampingmember 80 into circumferential groove 45 and over elongate outer member75. In embodiments, the insertion member 130 may be configured to pullthe clamping member 80. The coupling member 133 may include aninterference fit between the clamping member 80 and the insertion member130, or for example, the coupling member 133 may include a luer lock, orany suitable releasable latch. The coupling member 133 may be configuredto selectively release the clamping member 80 from the insertion member130 and/or may be configured to selectively re-attach the clampingmember 80 to the insertion member 130.

The clamping member 80/elongate outer member 75 (e.g., when it comprisesan elastic and/or compressible material, e.g., as described above) mayserve to dampen movement of the heart (e.g., caused by the beatingheart, e.g., pulse) by acting as a dampening and/or cushioning memberbetween the heart (e.g., a heart chamber) and the prosthesis 1 (e.g.,tubular body 30) to further improve the fixation of the prosthesis 1relative in the heart by reducing forces caused by the beating heartacting on the prosthesis 1 by dampening these forces. Accordingly, theclamping member 80/elongate outer member 75 may absorb movements (e.g.,of the ventricular wall (e.g., of the papillary muscle of theventricular chamber 20) to reduce or avoid pulsation of the prosthesis1. The clamping member 80 may serve to maintain a distance of theprosthesis 1 from tissue of the heart (e.g., from a wall of theventricular chamber 20 and/or the atrial chamber 15) and thereby improveplacement and/or fixation of the prosthesis 1. Accordingly, the elongateouter member 75 and/or the clamping member 80 may serve as a dampingmember and/or a spacer member. The clamping member 80 and/or theelongate outer member 75 and hence, the groove 45, may be arranged on aside of the ventricular chamber when seen from the annulus of thenatural valve having a distance from the annulus.

The shape of a cross section of tubular body 30 across its longitudinalaxis (e.g., axis 35) may vary. Catheter member 90 may comprise orprovide a piercing component that can be positioned through theconnection channel wall structure 25 (e.g., from an outside ofconnection channel wall structure 25) and through the tubular body 30 insubstantially diametrically opposite positions relatively to an axial(with respect to axis 35) cross section. The piercing component may behollow and enable placement of an anchor on connection channel wallstructure 25 at the distal position of a diameter of the connectionchannel wall structure 25 relatively to catheter member 90. Said anchormay be attached to a longitudinal end of a longitudinal component (e.g.,a tether), which in turn may be provided with a second anchor on itsother longitudinal end. The second anchor may be placed by the piercingcomponent upon retrieval of the piercing component from the connectionchannel wall structure 25 at the proximal end (relative to cathetermember 90) of said diameter on connection channel wall structure 25. Thelength of said longitudinal component can be designed to be undertension from forces acting on the longitudinal component induced by thefirst and second anchors, so as to create a deformation of tubular body30 in a substantially elliptical shape, e.g., the longitudinal componentmay be shorter than a diameter of the tubular body 30 when no externalforces act upon tubular body 30. The longitudinal component may beplaced across an inner lumen of tubular body 30 in a position where itdoes not interfere with the function of valve 40, e.g., be geometricallyspaced away from the valve 40. It may be small enough to avoidsignificant interference with blood flow through tubular body 30, e.g.,may have a radius or a diameter ranging from 100 μm to 1000 μm.

In embodiments, the transcatheter valve prosthesis 1 may include fabric120 disposed at least partially around the tubular body. For example, asshown in FIGS. 16a and 16b , the fabric 120 may be disposed around anouter circumference of tubular body 30 and over second end 69 ofprojection 55 such that the fabric forms a pouch 22 between the tubularbody 30 and projection 55. The pouch 122 serves to prevent tissue and/orthe clamping member 80 from sliding down too far between the tubularbody and projection 55. For example, the pouch 122 may correspond tochamber 66 disposed between tubular body 30 and projections 50 and/or55. In embodiments, the tubular body 30 may include the second pluralityof projections 55 and the fabric 120 may be disposed over the second end69 of the second plurality of projections 55 (FIG. 16b ). Inembodiments, the fabric 120 may be disposed over both the first andsecond plurality of projections 50, 55.

The fabric 120 may comprise liner 33 b, as described above, and mayinclude a first end 124 attached to the inflow end of the tubular body30 and a second end 126 as shown in FIGS. 16a and 16b . The fabric 120between the first end 124 and the second end 126 may include sufficientslack to form pouch 122. In embodiments, the second end 126 may beattached to the tubular body 30 in a vicinity of the outflow end of thetubular body 30. Alternatively, the second end 126 of the fabric 120 maybe attached to the second end 69 of a projection 50, 55, as shown inFIGS. 17a, 17b, 17c, 17d, and 17e . The second end 126 may be attachedat a very distal end of second end 69 (FIG. 17a ), or the second end 126may be attached at a connection point 167 that is adjacent to the verydistal end of second end 69 (FIGS. 17c and 17d ). The fabric 120 may beattached to the tubular body 30 or projection 50, 55 by, for example,sutures, adhesives, clamps, or any attachment means known in the art. Inembodiments, the second end 126 may be unattached to the tubular body 30and include a free end, as shown in FIG. 18. The free end of second end126 may extend substantially the entire length of stent 30 (FIGS. 16a,16b , and 18), or the free end of second end 126 may be shorter than thelength of the stent, for example as shown in FIGS. 17b-17e . In otherembodiments, the length of second end 126 may be shorter or longer thanthe embodiments shown in FIG. 16a through FIG. 18.

The fabric 120 may include one or more segments of material. Inembodiments, the fabric 120 includes one segment of material thatcompletely circumscribes the tubular body 30. In embodiments, the fabric120 may include multiple segments, for example, two, four, or six. Thesegments may be spaced apart, providing gaps between adjacent segments.Alternatively or in addition, some or all adjacent segments may overlap.The fabric 120 maybe continuous with, for example, liner 33 b (FIG. 6a). The fabric 120 may be made from polyester fabric (e.g., DACRON® orother PTFE graft material).

Elongate outer member 75 and clamping member 80 may be moved into thepouch 122 and trap tissue within the pouch 122, for example as shown inFIG. 17e . Movement of the elongate outer member and/or clamping member80 into the pouch 122 may provide tension on fabric 120, causing thefabric 120 to be taut. Thereby, the tissue may be trapped between thetubular body 30 and the projection 55. The fabric 120 may then locatedbetween the tubular body 30 and the trapped portions of tissue (e.g.,native valve leaflets and/or chords), and between the trapped portionsof tissue and the projection 55.

In embodiments, the fabric 120 may be attached to tubular body 30 withsufficient slack to form a pouch, but the pouch 122 may not be formeduntil elongate outer member 75 and/or clamping member 80 is/are movedinto contact with the fabric 120 between the tubular body 30 and theprojection 55. Then the elongate outer member 75 and/or clamping member80 forms the pouch 122 such that the size of the pouch 122 correspondsto the size of the elongate outer member 75 and/or clamping member 80.

As shown in FIGS. 26 and 27, the barbs 230 may be configured to at leastpartially pierce through fabric 120 when the barbs 230 pierce theportions of native valve leaflets and/or chords. The piercing of thefabric 120 by barbs 230 may help to secure the prosthesis to the nativevalve leaflets and/or chords.

All embodiments of the transcatheter valve prosthesis 1 may comprisepositioning and/or orientation devices to facilitate relative and/orabsolute positioning of the tubular body 30 and/or the elongate outermember 75 and/or the clamping member 80. These devices may includepassive markers that are fixedly attached to the tubular body 30 and/orthe elongate outer member 75 and/or the clamping member 80. The passivemarkers may be made from materials different from the materials of thetubular body 30 and/or the elongate outer member 75 and/or the clampingmember 80 in order to improve contrast during medical imaging, e.g.,using magnetic resonance or X-ray based imaging techniques. The passivemarkers may, e.g., be made of highly radio-opaque materials therebyallowing one to precisely acquire the relative and/or absolute positionof the components of the transcatheter valve prosthesis 1 with respectto the patient's body. The passive markers may each have an asymmetricalshape so as to allow identification of the absolute and/or relativeposition and orientation and thereby the position and orientation of thetubular body 30 and/or the elongate outer member 75 and/or the clampingmember 80. The passive markers may have an identical shape and may bearranged in a certain configuration relative to each other to allowrecognition of the orientation. The circumferential groove 45 of thetubular body 30 and/or the tubular body 30 and/or the elongate outermember 75 and/or the clamping member 80 may have passive markers fixedlyattached to facilitate positioning them relative to each other usingimaging techniques, e.g., passive markers made of highly radio-opaquematerials when imaging techniques based on electro-magnetic radiation(e.g., X-ray imaging) are used. In addition and/or as an alternative,the circumferential groove 45 and/or other parts/components of thetubular body 30 and/or the elongate outer member 75 and/or the clampingmember 80 may be made from radio-opaque materials.

A method for using a transcatheter prosthesis 1 as described above maycomprise:

-   -   Placing the transcatheter valve prosthesis 1 within an        atrio-ventricular valve, e.g., in a mitral or a tricuspid valve        of a human or animal heart, via an insertion catheter. The        transcatheter valve prosthesis 1 may, e.g., be placed in a        connection channel wall structure 25 between a ventricular        chamber 20 and an atrial chamber 15 as shown in FIG. 1.

To place transcatheter valve prosthesis 1 within the heart valve, thefollowing approaches may be applied: 1) an arterial retrograde approachentering the heart cavity over the aorta, 2) through a venous access andthrough a puncture through the inter atrial septum (trans-septalapproach), 3) over a puncture through the apex of the heart(trans-apical approach), 4) over a puncture through the atrial wall fromoutside the heart, 5) arterial access (e.g., from the femoral arterythrough a puncture in the groin), or 6) any other approach known to askilled person. The approach to the valve is facilitated as the tubularbody 30 is radially compressible and extendable and may, e.g., be foldedand stuffed in a catheter during approach and may be unfolded/extendedwhen within the circumferential connection channel wall structure 25.The transcatheter valve prosthesis 1 may include the clamping member 80or the clamping member 80 may be inserted separately via one of thementioned approaches (e.g., using a catheter) so as to be placed in thecircumferential groove 45 of the tubular body 30 when the tubular body30 is located in the connection channel wall structure 25. The clampingmember 80 may be compressible and expandable.

-   -   Fixing the transcatheter valve prosthesis 1 in the heart        relative to the valve.

For functional replacement of a heart valve, the transcatheter valveprosthesis 1 is fixed relative to the connection channel wall structure25 and sealed against blood flow on the exterior of the transcathetervalve prosthesis 1 in the connection channel wall structure 25. Toachieve this, tissue of the connection channel wall structure 25adjacent to the circumferential groove 45 may be forced or placed insidethe circumferential groove 45 to engage radially below the first 50 andsecond 55 pluralities of projections whereby the tissue is preventedfrom slipping out of the groove 45 by the first 50 and/or second 55plurality of projections, wherein the free ends 60, 65 of the first 50and/or second plurality 55 of projections may penetrate the tissue. Thetissue of the connection channel wall structure 25 may be (completely)perforated, or for example partially perforated, by the projections 50,55 and may thereby be prevented from slipping out of the circumferentialgroove 45. The clamping member 80 or two or more clamping members 80 maybe provided in the circumferential groove 45 to actively press tissue ofthe connection channel wall structure 25 against the free ends 60, 65 soas to interlock the tissue with the free ends 60, 65. This results inthe transcatheter valve prosthesis 1 being held in place more firmly andsealed against blood flow between the exterior of the tubular body 30and the connection channel wall structure 25.

To place tissue in the circumferential groove 45 of the tubular body 30,a method for using a transcatheter valve prosthesis 1 may comprise usingan elongate outer member 75 to radially and inwardly force tissue of dieconnection channel wall structure 25 into the circumferential groove 45(which may or may not comprise a clamping member 80). With reference toFIG. 3, the elongate outer member 75 may be disposed at an exterior ofthe connection channel wall structure 25 at a level of thecircumferential groove 45. Then, with further reference to FIG. 6b , adistance R5 between the elongate outer member 75 and the axis 35 of thetubular body is reduced (that means that also a distance between thebottom 46 of the circumferential groove 45 of the tubular body 30 andthe elongate outer member 75 is reduced) so as to force tissue of theconnection channel wall structure 25 into the circumferential groove 45to fix the tissue in the circumferential groove 45. In embodiments, theelongate outer member 75 slides along the slope of a partially deployedtubular body 30 to force tissue of the connection wall structure 25 intothe circumferential groove 45. The elongate outer member 75 may behandled via a catheter member 90 and an approach as described inrelation to the transcatheter valve prosthesis 1 or any other approachmay be used in order to bring the elongate outer member 75 into thevicinity of the connection channel wall structure 25.

After the elongate outer member 75 is disposed within thecircumferential groove 45 so as to fix tissue with the groove 45 and thetubular body 30 is fully deployed, the clamping member 80 may be guidedalong the elongate outer member 75 such that the clamping member 80 isdisposed over and coaxial with the loop of the elongate outer member 75within groove 45. For example, the clamping member 80 may be advancedbetween at least two stent struts 107 and/or projections on the tubularbody 30 in order to be slid over the elongate outer member 75. Theclamping member 80 may then trap the tissue (e.g., native valve leafletsand/or chords) within the circumferential groove 45. In embodiments, aninsertion member 130 may push the clamping member 80 between the stentstruts 107 and over the elongate outer member 75. A coupling member 133may release the insertion member 130 from the clamping member 80.

In embodiments, the clamping member 80 may be moved into thecircumferential groove 45 when the tubular body 30 is partiallydeployed. For example, when the outflow end but not the inflow end ofthe tubular body 30 is deployed from a delivery catheter such that thecircumferential opening of groove 45 is relatively larger (as comparedto when the tubular body 30 is fully deployed), the clamping member 80may be moved into the circumferential groove 45. The clamping member 80may be slid along the tubular body 30 (for example, in a direction fromthe outflow end toward the inflow end of the tubular body 30) into thecircumferential groove 45 to trap tissue within the groove.

When the tissue of the connection channel wall structure 25 is held inthe circumferential groove 45 by the projections 50, 55, the elongatedmember 75 (and the catheter member 90) may be removed from the heart or,as shown illustratively in FIG. 7, the connecting means 91 of thecatheter member 90 may be used in order to permanently connect two(free) ends of the elongate outer member 75 together and optionally cutthe ends so that elongate outer member 75 remains permanently on theexterior of a connection channel wall structure 25 on a level of thecircumferential groove 45 of the tubular body 30 so as to additionallyhold tissue of the connection channel wall structure 25 in thecircumferential groove 45.

In embodiments, elongate outer member 75 may radially and inwardly forcetissue of connection channel wall structure 25 into contact with fabric120 and between the tubular body 30 and the projection 55. This movementof elongate outer member 75 may guide native valve leaflets and/orchords into circumferential groove 45, wherein the circumferentialgroove 45 is formed between the tubular body 30 and the projection 55.Movement of elongate outer member 75 into circumferential groove 45 mayguide the native valve leaflets and/or chords into contact with fabric120 to form pouch 122. The fabric 120 may thus change from slack to tautto form pouch 122. The clamping member 80 may further be advanced intopouch 122 to trap the tissue within pouch 122.

In embodiments, the insertion member 130 may push the clamping member 80into the circumferential groove 45 and over the elongate outer member75. For example, the insertion member 130 may push the clamping member80 between at least two stent struts 107 and into the circumferentialgroove 45. The coupling member 133 may selectively release the clampingmember 80 from the insertion tube 130 after the clamping member 80 iswithin the circumferential groove 45 (FIG. 15c ). In embodiments,releasing and removing the elongate outer member 75 from the tubularbody 30 releases the clamping member 80 from the insertion member 130.The clamping member 80 and the insertion member 130 may be re-attachedwith the coupling member 130 after the step of releasing the clampingmember 80 from the insertion member 130. The clamping member 80 may thenbe repositioned within the patient. Additionally, the tubular body 30and elongate outer member 75 may also be repositioned within thepatient. After re-positioning the clamping member 80 within the patient,the coupling member 133 may re-release the clamping member 80 from theinsertion member 130.

A method for using the transcatheter atrio-ventricular prosthesis 1 mayresult in the transcatheter valve prosthesis 1 being fixed to theconnection channel wall structure 25 and being firmly held in place viathe tissue that is held in the circumferential groove 45 by the freeends 60, 65, optionally supported by the clamping member 80 and/or thepermanently disposed elongate outer member 75.

A method for using the transcatheter atrio-ventricular prosthesis 1 mayalso result in fixation of tubular body 30 to the connection channelwall structure 25 with minimal occlusion of the patient's valve. Forexample, the elongate outer member 75 may be advanced to the patient'snative valve within a first delivery catheter, for example through thepatient's femoral artery. The elongate outer member 75 may form a looparound the patient's native valve without substantially occluding thevalve. The tubular body 30 may be advanced to the patient's native valvewithin a second delivery catheter, for example through the patient'satrial wall. The tubular body 30 may be partially deployed from thesecond delivery catheter such that the outflow end but not the inflowend of the tubular body 30 is deployed from the second deliverycatheter. Only for the brief time that the tubular body 30 is partiallydeployed, the patient's native valve may be substantially occluded. Theelongate outer member 75 may then move into the circumferential groove45 when the tubular body is partially deployed, and thereby move thepatient's native valve leaflets and/or chords into the groove 45. Oncethe tubular body 30 is fully deployed, the patient's native valve may nolonger be substantially occluded. Therefore, the method may include onlysubstantially occluding the native valve only when the tubular body 30is partially deployed and not yet anchored in position by elongate outermember 75. Additionally, clamping member 80 may be advanced over theelongate outer member 75 without substantially occluding the nativevalve. For example, as discussed above, the clamping member may beadvanced over the elongate member 75 and around the fully deployed orpartially deployed tubular body 30.

Features of the transcather atrio-ventricular valve prosthesis 1 andmethod steps involving the prosthesis that have been described herein(description and/or figures and/or claims) referring to a transcatheratrio-ventricular valve prosthesis 1 comprising first 50 and second 55pluralities of projections also apply to a transcatheteratrio-ventricular valve prosthesis 1 comprising one plurality ofprojections (50, 55) and vice versa. In particular, features describedin the application (description, claims, figures) to further define theprojections of the first and second plurality of projections are alsoapplicable to only the first plurality of projections if, for example,the valve prosthesis only comprises the first plurality of projections.All features herein are disclosed to be interchangeable between allembodiments of the transcather atrio-ventricular valve prosthesis 1.

What is claimed is:
 1. A system for implanting a heart valve,comprising: a radially self-expandable tubular body having an inflow endand an outflow end and a preformed groove disposed at an outer surfaceof the tubular body between the inflow end and the outflow end, thepreformed groove extending at least partially around the tubular bodyand having a circumferential opening facing radially outward of thetubular body; and a trapping member configured to form at least apartial loop encircling the preformed groove so as to trap portions ofnative valve leaflets and/or chords in the preformed groove, thetrapping member including an inner member and an outer tube, wherein theouter tube includes a plurality of openings, and one or more barbs aredisposed on the inner member such that the one or more barbs areradially inward with regard to the inner member, when deployed, so thatthe one or more barbs are configured to pierce the native valve leafletsand/or chords when the tubular body is implanted in a patient; and thetubular body is configured to have a valve disposed therein and attachedthereto.
 2. The system according to claim 1, wherein the barbs extendaway from the trapping member, when the barbs are deployed, and thebarbs are configured to secure the system to the portions of nativevalve leaflets and/or chords.
 3. The system according to claim 2,wherein the barbs include a plurality of barbs that form a helicalshape, the helical shape being configured to secure a first portion ofthe native valve leaflets and/or chords and a second portion of thenative valve leaflets and/or chords together when the helical shape isrotated about its longitudinal axis.
 4. The system according to claim 1,wherein the inner member is configured to move relative to the outertube to substantially align the openings with the barbs so as to deploythe barbs through the openings.
 5. The system according to claim 4,further including a pusher tube releasably attached to the inner member,the pusher tube configured to push the inner member to move the innermember relative to the outer tube in a longitudinal direction of orrotationally to the inner member.
 6. The system according to claim 1,wherein the barbs are configured to assume a first deliveryconfiguration and a second deployment configuration, the deliveryconfiguration being substantially perpendicular to the deploymentconfiguration.
 7. The system according to claim 6, wherein the barbs areconfigured to be arcuate when in the second deployment configuration. 8.The system according to claim 1, further including an elongate outermember configured to form a loop encircling the preformed groove so asto guide the portions of native valve leaflets and/or chords into thepreformed groove.
 9. The system according to claim 1, further includinga projection having a first end located at a side surface of the tubularbody and a second free end and configured to define the preformed groovebetween the projection and the tubular body, the preformed groove havingan opening between the tubular body and the second free end of theprojection.
 10. The system according to claim 9, further including afabric configured to form a pouch between the tubular body and theprojection.
 11. The system according to claim 1, wherein the preformedgroove is defined by an indent in a side surface of the tubular body.12. The system according to claim 11, wherein the circumferentialopening of the preformed groove is larger than a maximum outer diameterof the trapping member.
 13. A system for implanting a heart valve,comprising: a radially self-expandable tubular body having an inflow endand an outflow end and a preformed groove disposed at an outer surfaceof the tubular body between the inflow end and the outflow end, thepreformed groove extending at least partially around the tubular bodyand having a circumferential opening facing radially outward of thetubular body; a trapping member configured to form at least a partialloop encircling the preformed groove so as to trap portions of nativevalve leaflets and/or chords in the preformed groove, the trappingmember including an inner member and an outer tube; and a projectionhaving a first end located at a side surface of the tubular body at adistance from a center of the preformed groove and a second free end,and configured to define the preformed groove between the projection andthe tubular body, the preformed groove having an opening between thetubular body and the second free end of the projection; wherein theouter tube includes a plurality of openings, and one or more barbs aredisposed on the inner member such that the one or more barbs areconfigured to pierce the native valve leaflets and/or chords when thetubular body is implanted in a patient; at least one of the barbs isconfigured to attach to the projection to secure the system to theportions of native valve leaflets and/or chords; and the tubular body isconfigured to have a valve disposed therein and attached thereto.
 14. Asystem for implanting a heart valve, comprising: a radiallyself-expandable tubular body having an inflow end and an outflow end anda preformed groove disposed at an outer surface of the tubular bodybetween the inflow end and the outflow end, the preformed grooveextending at least partially around the tubular body and having acircumferential opening facing radially outward of the tubular body; anda trapping member configured to form at least a partial loop encirclingthe preformed groove so as to trap portions of native valve leafletsand/or chords in the preformed groove, the trapping member including aninner member and an outer tube, wherein the outer tube includes aplurality of openings, and one or more barbs are disposed on the innermember such that the one or more barbs are configured to pierce thenative valve leaflets and/or chords when the tubular body is implantedin a patient; the one or more barbs comprise a first set of barbsconfigured to be oriented toward an inflow side of the groove when thetrapping member encircles the preformed groove, and a second set ofbarbs configured to be oriented toward an outflow side of the groovewhen the trapping member encircles the preformed groove; and the tubularbody is configured to have a valve disposed therein and attachedthereto.